Oral CF101 and Methotrexate Treatment in Rheumatoid Arthritis Patients

Study Type:	Interventional
Study Design:	Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
Condition:	Rheumatoid Arthritis
Intervention:	Drug: CF101

  Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
CF101 0.1mg	CF101 0.1 mg q12 hours orally
CF101 1mg	CF101 1mg q12 hours orally
CF101 4mg	CF101 4mg q12 hours orally
Placebo	Matching placebo q12 hours orally

Participant Flow:   Overall Study

	CF101 0.1mg	CF101 1mg	CF101 4mg	Placebo
STARTED	65	63	63	63
COMPLETED	63	57	57	61
NOT COMPLETED	2	6	6	2
Adverse Event	1	1	4	1
Change Therapy	1	2	0	0
Withdrawal by Subject	0	2	0	1
Noncompliance	0	1	2	0

  Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
CF101 0.1mg	CF101 0.1 mg q12 hours for 12 weeks
CF101 1mg	CF101 1 mg q12 hours for 12 weeks
CF101 4mg	CF101 4 mg q12 hours for 12 weeks
Placebo	Matching Placebo q12 hours for 12 weeks
Total	Total of all reporting groups

Baseline Measures

	CF101 0.1mg	CF101 1mg	CF101 4mg	Placebo	Total
Overall Participants Analyzed; [Units: Participants]	65	63	63	63	254
Age; [Units: Years]; Mean (Standard Deviation)	54.7 (12.02)	54.3 (9.98)	54.4 (10.07)	53 (10.86)	54.1 (10.73)
Gender; [Units: Participants]
Female	49	46	52	52	199
Male	16	17	11	11	55

  Outcome Measures

1. Primary:

ACR Efficacy Criteria [ Time Frame: 12 weeks ]

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2. Secondary:

ACR Criteria Components [ Time Frame: 12 weeks ]

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3. Secondary:

Safety [ Time Frame: 12 weeks ]

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  Serious Adverse Events

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  Other Adverse Events

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  Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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Certain Agreements:  

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  

Name/Title: Pnina Fishman, PhD
Organization: Can-Fite Biopharma
phone: 011972 39241114
e-mail: pnina@canfite.co.il

Publications:

Szabó C, Scott GS, Virág L, Egnaczyk G, Salzman AL, Shanley TP, Haskó G. Suppression of macrophage inflammatory protein (MIP)-1alpha production and collagen-induced arthritis by adenosine receptor agonists. Br J Pharmacol. 1998 Sep;125(2):379-87.

Baharav E, Bar-Yehuda S, Madi L, Silberman D, Rath-Wolfson L, Halpren M, Ochaion A, Weinberger A, Fishman P. Antiinflammatory effect of A3 adenosine receptor agonists in murine autoimmune arthritis models. J Rheumatol. 2005 Mar;32(3):469-76.

Responsible Party:	Can-Fite BioPharma
ClinicalTrials.gov Identifier:	NCT00280917 History of Changes
Other Study ID Numbers:	CF101-202RA
First Submitted:	January 23, 2006
First Posted:	January 24, 2006
Results First Submitted:	February 24, 2015
Results First Posted:	March 17, 2015
Last Update Posted:	March 17, 2015